Full Text View
Tabular View
No Study Results Posted
Related Studies
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
This study is currently recruiting participants.
Study NCT00071045   Information provided by National Institutes of Health Clinical Center (CC)
First Received: October 9, 2003   Last Updated: August 24, 2009   History of Changes

October 9, 2003
August 24, 2009
October 2003
December 2013   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00071045 on ClinicalTrials.gov Archive Site
 
 
 
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Collection of Blood, Bone Marrow, Urine, and/or Tissue Samples From Patients With Solid Tumors, Hematological Malignancies or Non-Malignant Hematologic Disorders or HLA Compatible Family Members

This study will collect biological samples for use in research experiments aimed at better understanding the clinical features of certain diseases. The specimens may be used to evaluate the effectiveness of known therapies, refine treatment approaches, identify potential new therapies, and explore opportunities for disease prevention.

The following individuals 2 years of age or older may be eligible for this study:

  • Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder who are being screened for or who are enrolled in a treatment study at the NIH Clinical Center
  • HLA-compatible donor family members (18 years of age or older) of the above patients who are being evaluated for or are enrolled in an NIH study as a stem cell transplant donor
  • Patients with a cancerous solid tumor or a cancerous or non-cancerous blood disorder or a bone marrow failure condition who cannot participate in an NIH treatment protocol or travel to the NIH Clinical Center and who are referred for participation through their home health care provider.

Research samples will be collected from participants when blood is drawn or bone marrow, urine, or stool is collected, or tumor or other tissue is biopsied as part of their general medical care. Investigators may periodically request an additional sample of blood, stool, or urine. Participants who are 18 years of age or older may donate a large number of white blood cells through a procedure called leukapheresis. This procedure is not part of general medical care and would be done for research purposes only. For apheresis, a catheter (plastic tube) is placed in a vein in the subject's arm. Blood flows from the vein into a cell separator machine, where the white cells are separated from the red cells, platelets, and plasma by a spinning process. The white cells are removed and collected, and the rest of the blood is returned to the subject through a second tube placed in the other arm.

The purpose of this protocol is to collect blood, bone marrow, urine, stool, buccal mucosa and/or both malignant and non-malignant tissue from patients who are either being evaluated for enrollment, are consented to NIH Clinical Center treatment protocols, or are receiving therapy for their disease through home health care providers. Since a substantial proportion of the clinical and translational research in the Hematology Branch involves patients undergoing allogeneic stem cell transplantation, this protocol will also be open to people identified as suitable HLA-compatible donors for patients undergoing evaluation for or already enrolled in an allogeneic stem cell transplant protocol or receiving a stem cell transplant through their home health care providers. These HLA-compatible donors will serve as a source of peripheral blood mononuclear cells (peripheral blood draws or leukapheresis) for use in evaluating allogeneic graft versus host and graft-versus-tumor effects.

 
Observational
Other
  • Neoplasms
  • Hematologic Neoplasms
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
 
 
December 2013   (final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:

The subject carries the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder, and is being screened at the NIH for eligibility for an NIH Clinical Center treatment protocol.

OR

The subject carries the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder, and is already enrolled on a clinical protocol at the NIH Clinical Center.

OR

The subject is a related HLA-compatible family member of a patient (bearing a diagnosis of malignant solid tumor or a malignant or non-malignant hematologic) being evaluated for or already enrolled on a clinical protocol at the NIH Clinical Center and is identified as a potentially suitable donor of allogeneic hematopoietic stem cells for transplantation.

OR

The subject carries the diagnosis of malignant solid tumor or a malignant or non malignant hematologic disorder or a bone marrow failure condition and is not available to participate in an NIH Clinical Center treatment protocol, or travel to the NIH clinical center, but is referred for participation through their home health care provider.

The subject or the subject's guardian is able to understand the investigational nature of the study and provide informed consent after initial counseling by clinical staff. Separate consent forms for all interventional or surgical procedures will be obtained after explanation of the specific procedure.

Age 2 years and older (no upper limit) when carrying the diagnosis of malignant solid tumor or a malignant or non-malignant hematologic disorder.

OR

Age 18 years and older if participating as an HLA compatible donor

EXCLUSION CRITERIA:

Subjects unable to comprehend the investigational nature of the procedure

Age less than 2 years (donors less than 18)

Both
2 Years and older
Yes
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010
United States
 
NCT00071045
 
040012, 04-H-0012
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Institutes of Health Clinical Center (CC)
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP